Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Celiac Disease in Children, Gluten-free Diet. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested. This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status. Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.
Primary outcome measures
- Adherence to a gluten-free diet - the Celiac Dietary Adherence Test. [Time frame: January 2026 - June 2027]
- Adherence to the gluten-free diet - the gluten immunogenic peptide in urine. [Time frame: January 2026 - June 2027]
- Adherence to the gluten-free diet - the gluten immunogenic peptide in stool. [Time frame: January 2026 - June 2027]
- Comparison of methods [Time frame: January 2026 - June 2027]
Secondary outcome measures (1)
- The nutritional status of Polish children with coeliac disease [Time frame: January 2026 - June 2027]
Eligibility criteria
Inclusion criteria
- diagnosis of coeliac disease according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
- age from 2 to 18 years of age,
- gluten-free diet use for at least 6 months,
- consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.
Exclusion criteria
- under 2 years of age and over 18 years of age,
- immunoglobulin A deficiency,
- inflammatory bowel diseases,
- gastrointestinal bleeding or other active bleeding,
- gastric and/or duodenal ulcers,
- liver failure,
- heart failure according to the NYHA II-IV scale,
- acute and chronic renal failure,
- cancer,
- after hematopoietic stem cell transplantation,
- whose legal guardians did not consent to participate in the study,
- who did not consent to participate in the study (applies to patients ≥ 16 years of age).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07157137 · CD-PL